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FDA 510(k)

SERAGARD VASCULAR ACCESS PATCH

K-Number: K001175 · 2000-09-18

ApplicantPlatinum Services, Inc.
Decision Date2000-09-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERAGARD VASCULAR ACCESS PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Platinum Services, Inc.. It received FDA 510(k) clearance on 2000-09-18 under 510(k) number K001175. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAGARD VASCULAR ACCESS PATCH?

SERAGARD VASCULAR ACCESS PATCH is a medical device that received FDA 510(k) clearance on 2000-09-18. The listed applicant is Platinum Services, Inc.. The 510(k) number is K001175.

When did SERAGARD VASCULAR ACCESS PATCH receive FDA 510(k) clearance?

SERAGARD VASCULAR ACCESS PATCH received FDA 510(k) clearance on 2000-09-18, under 510(k) number K001175.

Who is the listed applicant for SERAGARD VASCULAR ACCESS PATCH?

The FDA 510(k) record lists Platinum Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERAGARD VASCULAR ACCESS PATCH?

The FDA product code for SERAGARD VASCULAR ACCESS PATCH is FMI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Platinum Services, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001240SERAGARD INJECTION PATCH

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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